Back to Basics: GDPs & Reducing Regulatory Risk (2 of 2)

Welcome back!

In Part 1 of "Back to Basicss: GDPs & Reducing Regulatory Risk", we reviewed the real regulatory impacts of not following Good Documentation Practices. We also learned an easy way to remember the basic tenets of GDPs: ALCOA!

• Attributable
• Legible
• Contemporaneous
• Original
• Accurate

To help you apply these principles when documenting data or reviewing data, I have assembled this checklist of the most common GDP issues encountered. Please feel free to use and distribute!

Common GDP Watch-outs

• Do use indelible ink for handwritten entries.
• Don't use Pencils and Erasable pen inks for handwritten entries. Should not use fountain pens or other inks that smudge easily.  
• No correction fluids (e.g. Liquid Paper) allowed!
• Ensure all raw data is kept Keep all raw data - it cannot be destroyed!
• Don't use post its, scrap paper or other uncontrolled sheets to record data.
• Entries are initialed and dated at time they are made.
• Don't back-date or forward-date your entries!
• Ditto marks or continuation lines / arrows are not acceptable.
• Don't leave spaces blank designated for handwritten entries. Cross out or "N/A" and initial/date the blank spaces.
• Don't sign for another person or sign another person's name.
• If you need to correct an error:
• Put a single line through incorrect entry, write in new entry next to it, initial and date.
• Original entry must remain visible
• Reason for correction must be recorded
• Common abbreviations for entry error reasons that can be used are: EE – Entry Error, TE – Transcription Error, OW – overwrite.

Recommendations for Official Documents

• Each page of the document should have a unique identifying number - this way if a page gets detached, it is clear what document it belongs to
• Include revision/version number and effective dates
• Securely fasten all sheets document together
• Number each page of the document (x of y)
• Label each page of the attachment with document unique identifying number and attachment number
• Define abbreviations when first used in a document
• Always remember to write your documents such that any individual with no knowledge of your work or products can pick up the document and understand the premise.